It is used for treating erectile dysfunction and premature ejaculation.

Molecular structure

Technical Test Sheet (TTS) of Sex Steroid Hormones Vardenafil

Test Items

Specification

Test Results

Description

White or almost white crystalline powder

White crystalline powder

Melting Point

191.0~193.0ºC

192ºC

Loss of drying

≤1.0%

0.5%

Heavy Metal

≤20ppm

15ppm

TLC

Only one spot

Only one spot

Assay

≥99.5%

99.91%

Conclusion

It complies with the USP 32.

Brief Dexcription of Sex Steroid Hormones Vardenafil

Vardenafil (INN) is a PDE5 inhibitor used for treating erectile dysfunction that is sold under the trade names Levitra (Bayer AG, GSK, and SP), Staxyn in India, and Vivanza in Italy.

Vardenafil was co-marketed by Bayer Pharmaceuticals, GlaxoSmithKline, and Schering-Plough under the trade name Levitra. As of 2005, the co-promotion rights of GSK on Levitra have been returned to Bayer in many markets outside the U.S. In Italy, Bayer sells vardenafil as Levitra and GSK sells it as Vivanza. Thus, because of European Union trade rules, parallel imports might result in Vivanza sold next to Levitra in the EU.

An orally disintegrating form, marketed as Staxyn and Levitra Soft. has been gaining approvals in countries such as the United States and Canada.

Indication and Usage of Sex Steroid Hormones Vardenafil

Vardenafil's indications and contra-indications are the same as with other PDE5 inhibitors; it is closely related in function to sildenafil citrate (Viagra) and tadalafil (Cialis). The difference between the vardenafil molecule and sildenafil citrate is a nitrogen atom's position and the change of sildenafil's piperazine ring methyl group to an ethyl group. Tadalafil is structurally different from both sildenafil and vardenafil. Vardenafil's relatively short effective time is comparable to but somewhat longer than sildenafil's.

Beyond its indications for erectile dysfunction, vardenafil may be effective in the treatment of premature ejaculation, where it may significantly increase the time from penetration to ejaculation.

Dosage Form of Sex Steroid Hormones Vardenafil

It is available in 2.5 mg, 5 mg, 10 mg, and 20 mg doses in round orange tablets. The normal starting dose is 10 mg (roughly equivalent to 50 mg of sildenafil). Vardenafil should be taken 1 to 2 hours prior to sexual activity, with a maximum dose frequency of once per day. In some territories, such as the UK, only certain doses may be available.

Vardenafil is also available under the name Staxyn as a tablet which dissolves on the tongue rather than being swallowed in the form of a pill.

The recommended dosage of Staxyn is one 10 mg tablet taken 60 minutes before sexual activity. Certain antidepressants, antifungal, antibiotic, heart, and blood pressure medications can interact with Staxyn. Tell your doctor all medications you use.

What are the precautions when taking Sex Steroid vardenafil hcl (Levitra) ?

Before taking vardenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Taking a nitrate medicine with Staxyn can cause a sudden and serious decrease in blood pressure. Contact your doctor or seek medical attention if your erection lasts for more than 4 hours. Staxyn is not indicated for women who are of child bearing years and therefore should not be taken if you are pregnant or breastfeeding.

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